(56 days)
Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.
Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate.
This is a 510(k) summary for a dental retraction cord (Stay-put impregnated), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of device performance against pre-defined acceptance criteria in the way a novel diagnostic or therapeutic device might.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this type of submission. The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's an attempt to answer your questions based on the provided text, and where information is not available, I will state that:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Premarket Pathway: Substantial Equivalence to Predicate Device | Stay-put impregnated is substantially equivalent to Ultrapak E. |
| Material Composition: Impregnated retraction cord. | Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate. |
| Intended Use: Temporary retraction and hemostasis of the gingival margin. | Stay-put impregnated is indicated for the temporary retraction and hemostasis of the gingival margin. |
| Technical Characteristics: Similar to predicate device. | "The technical characteristics are similar to those found with the predicate device Ultrapak E." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission does not describe a clinical study with a "test set" in the context of device performance evaluation as it would for a new diagnostic or therapeutic device. The submission focuses on demonstrating substantial equivalence based on material composition, intended use, and technical characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of a test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental retraction cord, not an AI-powered diagnostic tool, so an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this 510(k) is primarily the established safety and effectiveness profile of the predicate device, Ultrapak E, as the new device is claiming substantial equivalence to it. No independent ground truth establishment for a novel performance claim is detailed.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device or a clinical trial with a training phase.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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510(k) Submission Stay-put impregnated 510(k) Summary
JUN 1 5 2004
Image /page/0/Picture/2 description: The image shows the logo for "coltène whaledent". The word "coltène" is in lowercase letters and is stacked on top of the word "whaledent", which is also in lowercase letters. There are three diagonal lines to the right of the word "coltène". The logo is in black and white.
This summary of 510 (k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR § 807.92.
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The submitter of this premarket notification is: Coltène/Whaledent Inc. Henry Vogelstein 235 Ascot Parkway Cuyahoga Falls, OH 44223-3701 USA Tel.: (212) 289-4748 Fax: (212) 289-4748 This summary was prepared on February 20, 2004
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The name of this device is Stay-put impregnated. Its common name is Stay-put impregnated and its classification is retraction cord.
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Stay-put impregnated is substantially equivalent to Ultrapak E manufactured by Ultradent Products Inc.
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Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate.
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The technical characteristics are similar to those found with the predicate device Ultrapak E. Both products are impregnated retraction cords for dental use. Differences are only in the compression aid.
H. Hogelster 4/19/04
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2004
Coltene/Whaledent Incorporated C/O Mr. Henry J. Vogelstein Official Correspondent Designated U.S. Agent 1349 Lexington Avenue New York, New York 10128
Re: K041023
Trade/Device Name: Stay-Put Impregnated Regulation Number: N/A Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Codes: MVL Dated: April 19, 2004 Received: April 20, 2004
Dear Mr. Vogelstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your contentially equivalent (for the indications for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass succed in also encreat date of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic nave been rochassiriou in approval of a premarket approval application (PMA). You may, Act (Tec) market the device, subject to the general controls provisions of the Act. The general thereore, mancer me act include requirements for annual registration, listing of devices, good controle pro reserved labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sam adations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Page 2 - Mr. Henry J. Vogelstein
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Anthony 20. nater for
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/1 description: The image shows the logo for "coltène whaledent". The word "coltène" is in lowercase letters and is stacked on top of the word "whaledent", which is also in lowercase letters. There are three diagonal lines to the right of the word "coltène".
Indications for Use
KO41023 510(k) Number (if known):
Device Name:
Stay-put impregnated
Indications for Use:
Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.
Prescription Use (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruaper
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental
510(k) Number: K6411023
N/A